(73 days)
For in vitro diagnostic use only. VITROS Chemistry Products dTIBC Reagent is used to quantitatively measure total iron-binding capacity (TIBC) in human serum. The iron binding capacity is useful in the differential diagnosis of anemia, iron deficiency anemia, thalassemia, sideroblastic anemia, and iron poisoning.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 29 is used to calibrate VITROS 5,1 FS Chemistry Systems for the quantitative measurement of total iron-binding capacity (TIBC) using VITROS Chemistry Products dTIBC Reagent.
For in vitro diagnostic use only. VITROS Chemistry Products Performance Verifiers are assayed controls intended for use in monitoring performance on VITROS Chemistry Systems.
The VITROS Chemistry Products dTIBC Reagent is a dual chambered package containing ready-to-use liquid reagents. Reagent 1, an acidic buffer containing ferric ions bound to chromazurol B (iron-binding dye) is added to the sample. The acidic pH releases iron from transferrin and the released iron binds to the excess chromazurol B. Reagent 2, a neutral buffer is added, shifting the pH, which results in increased affinity of transferrin for iron. Serum transferrin rapidly extracts iron from the dye-iron complex. The decrease in absorbance of the colored dye-iron complex is directly proportional to the total iron-binding capacity of the sample and is measured spectrophotometrically at 660 nm. Once a calibration has been performed, the TIBC concentration in each unknown sample can be determined using the I TDO collection curve and the measured absorbance obtained in the assay of the sample. The VITROS Chemistry Products Calibrator Kit 29 is a two level standard used to calibrate VITRÓS 5,1 FS Chemistry Systems for the quantitative measurement of total iron binding capacity (TIBC). VITROS Calibrator Kit 29 level 1 is an aqueous solution containing processed bovine serum albumin, and preservative. VITROS Calibrator Kit 29 level 2 is a lyophilate containing processed human serum, proteins, enzymes, organic compounds, electrolytes, immunoglobulins, inorganic compounds, hormones, and metals. The VITROS Chemistry Products FS Reconstitution Diluent is processed water used to reconstitute the VITROS Calibrator Kit 29 level 2. The VITROS Chemistry Products Performance Verifiers I and II are lyophilized materials prepared from processed human serum to which enzymes, electrolytes, stabilizers, preservatives, and other organic analytes have been added. The lypohilate is reconstituted using diluent manufactured from processed water to which inorganic salts have been added. These are assayed quality control materials are used to monitor the performance of the VITROS dTIBC assay on the VITROS 5,1 FS System. The VITROS dTIBC assay utilizes VITROS Chemistry Products FS Diluent Pack 2 (BSA/Saline), a common reagent that is used by multiple assays on the VITROS 5,1 FS System. This is a dual chambered package containing two ready-to-use liquid diluents. Diluent 1 (Saline) is prepared from processed water to which inorganic salt has been added. Diluent 2 (BSA) is prepared from processed water to which bovine serum albumin, inorganic salts and preservatives have been added. The VITROS 5,1 FS Chemistry System is a clinical chemistry instrument that provides automated use of the VITROS Chemistry Products MicroTip® and MicroSlides® range of products.
The provided document, K052867, describes a premarket notification for the VITROS Chemistry Products dTIBC Reagent, Calibrator Kit 29, and Performance Verifiers I & II. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, rather than outlining specific, quantitative acceptance criteria for device performance and detailed study results that would typically be found in a more comprehensive clinical trial report.
Therefore, much of the requested information, such as detailed quantitative acceptance criteria with specific thresholds, sample sizes for test sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and explicit standalone performance, is not present in this 510(k) summary. The document highlights the comparison to predicate devices to demonstrate equivalence, rather than providing a detailed performance study against pre-defined acceptance criteria.
However, based on the provided text, I can infer and summarize the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a pass/fail format with specific numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" based on correlation studies and bench testing for various assay characteristics.
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (VITROS dTIBC vs. Predicate) |
|---|---|---|
| Correlation | High correlation coefficient with predicate device. | Correlation coefficient: 0.981 |
| Linear relationship with predicate device. | Equation: VITROS dTIBC = 0.94X + 12.99 (µg/dL) | |
| Intended Use | Same as predicate device. | Same: Quantitative measurement of TIBC in human samples. |
| Sample Type | Same/comparable to predicate device. | Difference: Human Serum (VITROS) vs. Human Serum and plasma (Predicate) |
| Reportable Range | Consistent with clinical utility; comparable to predicate. | Difference: 60 - 650 µg/dL (VITROS) vs. 0 - 1000 µg/dL (Predicate) |
| Calibrators | Clinically appropriate; comparable to predicate. | Difference: Two levels (VITROS) vs. Three levels (Predicate) |
| Precision | Expected to be within acceptable analytical limits (not quantified in summary). | Performed (bench testing), but specific results not reported. |
| Linearity | Expected to be linear across reportable range (not quantified in summary). | Performed (bench testing), but specific results not reported. |
| Specificity | Expected to be adequate (not quantified in summary). | Performed (bench testing), but specific results not reported. |
| Limit of Detection | Expected to be clinically relevant (not quantified in summary). | Performed (bench testing), but specific results not reported. |
| Dilution | Expected to demonstrate appropriate performance (not quantified in summary). | Performed (bench testing), but specific results not reported. |
| Specimen Matrix | Expected to demonstrate appropriate performance (not quantified in summary). | Performed (bench testing), but specific results not reported. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The text mentions "patient samples" were used for equivalence testing.
- Data Provenance: Not specified regarding country of origin or whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable and not provided. For this type of in vitro diagnostic device (quantitative assay), the "ground truth" is typically established by the reference method or the predicate device's established performance, not by expert interpretation of images or other subjective assessments.
4. Adjudication method for the test set
- This information is not applicable and not provided for this type of in vitro diagnostic device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is an in vitro diagnostic assay, not an AI-powered image analysis or diagnostic aid for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The device is a standalone in vitro diagnostic assay. Its performance is measured directly, not in conjunction with a human operator making interpretive decisions based on the assay's output. The output (a quantitative TIBC value) is directly reported.
7. The type of ground truth used
- The "ground truth" for demonstrating substantial equivalence was the performance of the predicate device (Dade Behring Total Iron Binding Capacity (IBCT) Flex® assay on the Dimension® clinical chemistry systems). The new device's measurements were compared against the predicate's measurements on the same samples.
8. The sample size for the training set
- This information is not applicable and not provided. This device is a chemical reagent-based assay, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- This information is not applicable and not provided, as there is no "training set" for this type of device.
§ 862.1415 Iron-binding capacity test system.
(a)
Identification. An iron-binding capacity test system is a device intended to measure iron-binding capacity in serum. Iron-binding capacity measurements are used in the diagnosis and treatment of anemia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.